高清经颅直流电刺激治疗轻度创伤性脑损伤 (HDtDCS-TBI)
高清经颅直流电刺激治疗轻度创伤性脑损伤的言语提取缺陷
The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., presupplementary motor area) thought to aid in memory will improve verbal retrieval in military veteran participants with histories of traumatic brain injuries. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures. Additionally, the study will examine the degree to which baseline assessments of cognition and concussion history predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.
研究概览
详细说明
Using two treatment arms, the study will examine improvement of verbal retrieval and other cognitive deficits associated with remote traumatic brain injury by comparing (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 15 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and 3-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 15 sessions and will be and re-evaluated at 2- and 3-months follow-up testing sessions.
Veterans with histories of traumatic brain injuries and observed cognitive deficits will be randomly assigned to one of the two treatment arms (and re-assigned for the second round of intervention, as described above). Primary outcome verbal retrieval measures, secondary neuropsychological and electroencephalography (EEG) measures, and prescreening assessments for study concussion history and contraindications for treatment will be collected prior to being assigned to a treatment arm (i.e., baseline).
Primary outcome verbal retrieval measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected after treatment sessions 5, 10, and 15 and two times following treatment competition (i.e., 2-months and 3-months). For participants selected for the second round of intervention, primary outcome verbal memory measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected again after treatment sessions 5, 10, and 15 and two times following competition of the second treatment (i.e., 2-months and 3-months).
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jill Ritter, BS
- 电话号码：972-883-3161
- 邮箱：neurolab.memory@utdallas.edu
研究联系人备份
- 姓名：Tyler Vintila
- 电话号码：972-883-3161
- 邮箱：neurolab.memory@utdallas.edu
学习地点
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Texas
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Dallas、Texas、美国、75235
- 招聘中
- The University of Texas at Dallas
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副研究员：
- Michael Motes, PhD
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接触：
- Ashna Adhikari
- 电话号码：972-883-3161
- 邮箱：neurolab.memory@utdallas.edu
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接触：
- Tyler Vintila
- 电话号码：972-883-3161
- 邮箱：neurolab.memory@utdallas.edu
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria: Participants are to be between the ages of 18-75, have previously served in the US armed services, and have had a traumatic brain injury that has led to a verbal retrieval deficit based on neuropsychological testing criteria. Traumatic brain injury must be in the mild to moderate range based on evaluation, including, the Ohio State TBI Identification Method (administered by our research group). You must be fluent in speaking and reading English.
Exclusion Criteria: Exclusion criteria include a history of a psychological or neurological disorder, including, dementia of any type, epilepsy or other seizure disorders, severe traumatic brain injury, post-traumatic stress disorder, brain tumor, present drug abuse, stroke, blood vessel abnormalities in the brain, Parkinson's disease, Huntington's disease, or multiple sclerosis. Additionally, exclusion criteria include inability to give informed consent; cranial implants or skull defects that affect tDCS administration; and use of medications that interact with or potentially interact with tDCS effects, including, anti-convulsants, amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole, or citalopram.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Transcranial direct current stimulation
20 minutes of 1 milliamp transcranial direct current stimulation to presupplementary motor area for 15 sessions |
Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.
其他名称：
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假比较器：Sham transcranial direct current stimulation
20 minutes of sham transcranial direct current stimulation to presupplementary motor area for 15 sessions |
Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Controlled Oral Word Association Test
大体时间：Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
Evaluation of treatment group differences in change on the Control Word Association Test from baseline to 3-months. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., & Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates. |
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Controlled Oral Word Association Test
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change on the Control Word Association Test from baseline to 2-months. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., & Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates. |
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 3-months Post-Treatment in Category Fluency
大体时间：Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
Evaluation of treatment group differences in change in Category Fluency from baseline to 3-months. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., & Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates. |
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment in Category Fluency
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change in Category Fluency from baseline to 2-months. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., & Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates. |
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Semantic Object Retrieval Test
大体时间：Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
Evaluation of treatment group differences in change in Semantic Object Retrieval Test from baseline to 3-months. Metric: Number of Correct Retrievals Kaplan, E., Goodglass, H., & Weintraub, S., (1983). Boston Naming Test (2nd ed.). Lea & Febiger: Philadelphia. |
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval Test
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change in Semantic Object Retrieval Test from baseline to 2-months. Metric: Number of Correct Retrievals Kaplan, E., Goodglass, H., & Weintraub, S., (1983). Boston Naming Test (2nd ed.). Lea & Febiger: Philadelphia. |
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Boston Naming Test
大体时间：Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
Evaluation of treatment group differences in change in Boston Naming Test from baseline to 3-months. Metric: Number of Correct Names Retrieved Kraut, M.A., Cherry, B., Pitcock, C.B., Anand, R., Li, J. Vestal, L., Henderson, V.W., and Hart, J. Jr. (2007). The Semantic Object Retrieval Test (SORT) in amnestic cognitive impairment. Cogn. Behav. Neurol. 20, 62- 67. |
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Boston Naming Test
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change in Boston Naming Test from baseline to 2-months. Metric: Number of Correct Names Retrieved Kraut, M.A., Cherry, B., Pitcock, C.B., Anand, R., Li, J. Vestal, L., Henderson, V.W., and Hart, J. Jr. (2007). The Semantic Object Retrieval Test (SORT) in amnestic cognitive impairment. Cogn. Behav. Neurol. 20, 62- 67. |
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 3-months Post-Treatment on California Verbal Learning Test
大体时间：Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
Evaluation of treatment group differences in change in California Verbal Learning Test from baseline to 3-months. Metric: Number of Correct Retrievals Delis DC, Kramer JH, Kaplan E, Ober BA. (2017). California verbal learning test (3rd Ed.). Pearson Publishing: San Antonio, TX. |
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on California Verbal Learning Test
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change in California Verbal Learning Test from baseline to 2-months. Metric: Number of Correct Retrievals Delis DC, Kramer JH, Kaplan E, Ober BA. (2017). California verbal learning test (3rd Ed.). Pearson Publishing: San Antonio, TX. |
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Trail Making Test (Part A)
大体时间：Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
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Evaluation of treatment group differences in change on the Trail Making Test (Part A) from baseline to 3-months. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276. |
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part A)
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change on the Trail Making Test (Part A) from baseline to 2-months. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276. |
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Trail Making Test (Part B)
大体时间：Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
Evaluation of treatment group differences in change on the Trail Making Test (Part B) from baseline to 3-months. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276. |
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part B)
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change on the Trail Making Test (Part B) from baseline to 2-months. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276. |
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Delis Kaplan Color Word Interference Test
大体时间：Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
Evaluation of treatment group differences in change on the Delis Kaplan Color Word Interference Test from baseline to 3-months. Metric: Time to Name Items Delis, D.C., Kaplan, E., & Kramer, J.H., (2001). Delis-Kaplan Executive Function System. San Antonio, TX: The Psychological Corporation. |
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Delis Kaplan Color Word Interference Test
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change on the Trail Making Test (Part B) from baseline to 2-months. Metric: Time to Name Items Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276. |
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Digit Span Forward
大体时间：Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
Evaluation of treatment group differences in change in Digit Span Forward from baseline to 3-months. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson. |
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Forward
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change in Digit Span Forward from baseline to 2-months. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson. |
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Digit Span Backward
大体时间：Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
Evaluation of treatment group differences in change in Digit Span Backward from baseline to 3-months. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson. |
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Backward
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change in Digit Span Backward from baseline to 2-months. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson. |
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Rey-Osterrieth Complex Figure Test
大体时间：Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
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Evaluation of treatment group differences in change in Rey-Osterrieth Complex Figure Test scores from baseline to 3-months. Metric: Score Rey, A. (1941). L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). [The psychological examination in cases of traumatic encepholopathy. Problems.]. Archives de Psychologie, 28, 215- 285. |
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Rey-Osterrieth Complex Figure Test
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change in Rey-Osterrieth Complex Figure Test scores from baseline to 2-months. Metric: Score Rey, A. (1941). L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). [The psychological examination in cases of traumatic encepholopathy. Problems.]. Archives de Psychologie, 28, 215- 285. |
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Digit Symbol Substitution Test
大体时间：Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
Evaluation of treatment group differences in change on the Digit Symbol Substitution Test from baseline to 3-months. Metric: Number of Items Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson. |
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Symbol Substitution Test
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change on the Digit Symbol Substitution Test from baseline to 2-months. Metric: Number of Items Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson. |
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Grooved Pegboard Test
大体时间：Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
Evaluation of treatment group differences in change on the Grooved Pegboard Test from baseline to 3-months. Metric: Completion Time Matthews, C.G., and Klove, H. (1964). Instruction manual for the adult neuropsychology test. Madison. Wis: University of Wisconsin Medical School. |
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
|
|
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Grooved Pegboard Test
大体时间：Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
Evaluation of treatment group differences in change on the Grooved Pegboard Test from baseline to 2-months. Metric: Completion Time Matthews, C.G., and Klove, H. (1964). Instruction manual for the adult neuropsychology test. Madison. Wis: University of Wisconsin Medical School. |
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
|
合作者和调查者
调查人员
- 首席研究员：John Hart, MD、The University of Texas at Dallas
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- UTD-TDCSTBI-21-15
- CDMRP-PT190081 (其他标识符：CDMRP)
- W81XWH-20-1-0846 (其他赠款/资助编号：DOD-CDMRP-USAMRDC)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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